Method and composition for reducing the tobacco consumption of a human while freshening the breath from tobacco odors

ABSTRACT

The present invention provides a composition which is useful for reducing tobacco consumption in humans while providing fresh breath comprising Plantago major and an additive for diminishing the odor of tobacco. The additives may be any breath freshener, masking agents, antiseptic agents and neutralizing agents. The present invention also provides a method for reducing the consumption of tobacco while providing fresh breath through the oral administration of a composition comprising Plantago major and an additive for diminishing the odor of tobacco.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] This invention relates to a method and composition for reducingthe tobacco consumption of a human while freshening the breath fromtobacco odors. More specifically, this invention relates to acomposition, containing Plantago major, for reducing tobacco comsumptionwhile diminishing tobacco odors in the mouth.

[0003] 2. Description of Related Art

[0004] The use of tobacco products has been shown to be a major healthrisk affecting all age groups and cutting across all socioeconomiclevels. According to the American Heart Association, cigarette smokingis the most important preventable cause of premature death in the UnitedStates. Smokers' risk of heart attack is more than twice that ofnonsmokers. Cigarette smoking is The biggest risk factor for suddencardiac death: Smokers have two to four times the risk to nonsmokers.Studies have shown cigarette smoking to be an important risk factor forHeart attack Available evidence also indicates that chronic exposure toenvironmental tobacco smoke (secondhand smoke, passive smoking) mayincrease the risk of heart disease.

[0005] Studies have also shown that of the estimated 47 million smokersin the United States, more than 32 million report a desire to quit.Nicotine replacement therapy (NRT) has been shown to be safe andeffective in helping people stop using cigarettes when used as part of acomprehensive smoking cessation program. NRT medicines are available asgum and patches over-the-counter and as nasal sprays and puffers(“inhalers”) by prescription. The consistent use of one of theseproducts doubles the chances of success with stopping smoking.Behavioral changes and support are essential to success in conjunctionwith the NRT's and generally, the more intense the behavior modificationtherapy, the greater the chance of success.

[0006] One such product which may be used for helping in the cessationof tobacco product consumption is disclosed U.S. Pat. No. 4,284,089entitled Simulated Smoking Device, issued to Jon P. Ray. Ray discloses asimulated smoking device, adapted for non-burning or non-combustion usesand consists of a container defining a passageway having a vaporizablenicotine source therein. As with tobacco consumption, a product, such asthe one disclosed in Ray, suffers from its use of nicotine to preventthe need for tobacco.

[0007] Natural products, which may also aid in the reduced consumptionof tobacco, have also been proposed. U.S. Pat. No. 5,716,635 entitledPlantago Major Transdermal Patch For Use In Treating A Tobacco OrNicotine Habit, issued to Mary E. Cody discloses a Plantago majortransdermal patch for use in treating a tobacco or nicotine habit.Similarly, U.S. Pat. No. 6,063,401 entitled Plantago Major And HypericumPerforatum Compound For Use In Treating A Tobacco Or Nicotine Habit,also issued to Mary E. Cody, discloses a Plantago major and Hypericumperforatum compound for us in treating a tobacco or nicotine habit. Thedifficulty with the transdernal patch proposed by Cody is that the usermust wear the patch continually to deliver the necessary amounts ofPlantago major extract. This prevents the user from regulating theamount of extract necessary throughout the day.

[0008] The compound of ‘Cody '401’ also discloses a smoking cessationaid including the herb Plantago major, but with the addition ofHypericum perforatum. The ‘Cody '401’ composition includes Hypericumperforatum, an anti-depressive, to help with the psychological effectsassociated with nicotine withdrawal after a tobacco user has ceasedconsuming nicotine-containing products. The disadvantage encounteredwith this product is the necessity of ingesting an anti-depressive inconjunction with a smoking-cessation aid. Many in the tobacco consumingpublic might be adverse to the use of an anti-depressive, either due toan aversion to such products or their current use of other medications.

[0009] A secondary concern for tobacco consumers, and which may be justas detrimental, is the offensive breath which is commonly evident aftertobacco consumption. Not only is the tobacco consumer detrimentallyaffecting their health, but simultaneously damaging their socialinteractions due to the offensive odor emitted from their mouths. Thisadditional, psychological effect of tobacco consumption may furthercompound the health risks encountered by tobacco consumers. In thisaspect, it is well know of the large number of breath freshenersavailable to consumers which attempt to conceal the smell of tobacco.Products which assist in the cessation of tobacco consumption aresometimes formulated with flavored additives, but only for making theproduct more palatable for the consumer and to cover-up the flavorsusually associated with smoking cessation aids.

[0010] In light of the prior art, there currently exists a need for aproduct which assists tobacco consumers in their fight to reduce theirtobacco intake while masking the offensive odor which remains after suchtobacco consumption.

SUMMARY OF THE INVENTION

[0011] One object of the invention is therefore to provide a productwhich reduces the urge for tobacco consumption.

[0012] A further object of the invention is to provide a product whichhelps diminish the odor which remains in the mouth after consumption oftobacco.

[0013] Another object of the invention is to provide for both an aid forthe cessation of tobacco consumption while diminishing the odor left inthe mouth after said consumption of tobacco.

[0014] A further object of the invention is to provide for a method ofdelivering an aid for cessation of tobacco consumption whilesimultaneously diminishing the odor of the tobacco consumed.

[0015] Accordingly, the present invention provides a composition forreducing tobacco consumption in humans while providing fresh breathcomprising Plantago major and an additive for diminishing the odorcharacteristics of tobacco. The additives may be any masking agents,antiseptic agents, neutralizing agents, breath fresheners, mint,licorice, cherry, cinnamon, spearmint, peppermint, anis, garlic, clove,and coffee.

[0016] The present invention also provides a method for reducing theconsumption of tobacco while providing fresh breath through the oraladministration of a composition comprising Plantago major and anadditive for diminishing the odor characteristics of tobacco.

DETAILED DESCRIPTION

[0017] The present invention provides a composition comprising Plantagomajor in combination with a tobacco odor diminishing agent for helpingconsumers of tobacco reduce, or quit, such consumption while diminishingthe odor of tobacco during the period of reduction in tobaccoconsumption.

[0018] The natural product used in the present invention is extractedfrom the plant Plantago major. Plantago major belongs to thePlantaginaceae family and is otherwise know as the ‘common plantain’ orthe ‘great plantain.’ The plant consists of a basal rosette of leaveswhich abruptly contract into long petioles, and have a cylindrical spikeof up to 50 cm in height. The extract is derived from the dried leavesof the plant during its flowering period. The extraction process may becarried out using any of the commonly known techniques, such as alcoholand/or water extraction.

[0019] The beneficial effects of the Plantago major extract are derivedfrom the compound aucubin, a pyridine monoterpene alkaloid. Thisparticular glycoside has been shown to exhibit efficacy as a suppressantin tobacco consumption. Additionally, aucubin has been shown to includeanti-inflammatory and antispasmodic activity as well as protection ofthe liver against the toxic effects of chemicals such as carbontetrachloride, possibly due to the inhibition of cytochrome P-450activity. Plantago major additionally appears to induce a temporarystate of relaxation, helping further to mitigate the need for tobaccoconsumption. Although nicotine has been shown to possess detrimentalcardiac effects, Plantago major, to date has not been shown to bringabout any adverse cardiac side effects.

[0020] The Plantago major extract of the present invention may beincluded in a composition meant for oral ingestion. Alternatively, thePlantago major extract may be added to the composition of the presentinvention as a homeopathic preparation. Homeopathic preparations arebased on the therapeutic approach of administering drugs to a person inneed thereof, which would normally bring about symptoms, similar to thedisease state, in a healthy person. A feature of the homeopathicapproach is the administration of the treating composition in very lowdoses, but sufficient to bring about the desired therapeutic effect.

[0021] A homeopathic remedy may be diluted and rediluted several hundredtimes. This method of preparing a remedy is called potentization,whereby a remedy is continually diluted to the point of final dilutionswhich may be 1 part in 1 million. The preparations are normally atlevels which, at pharmacological or toxic doses, cause symptoms thatmimic those which are the subject of the treatment.

[0022] The preparation of Plantago major used in the present inventionmay then be combined with an additive for diminishing the odorcharacteristics of tobacco. These agents may be, for example, maskingagents, neutralizing agents and antiseptic agents. Masking agents areprimarily used for covering or hiding smells. These agents do not removesmells but compete with the odors found in the mouth. Examples ofmasking agents include breath fresheners such as mint, licorice, cherry,cinnamon, spearmint, peppermint, anis, cloves and coffee flavorings:either naturally derived or synthetic.

[0023] Antiseptic agents partially correlate with the masking agents dueto the antiseptic qualities of some of the masking agents. Examples ofthese antiseptics include some of the essential oils of plants such asmint, spearmint, peppermint and licorice as well as alcohol, thymol,menthol, eucalyptol and methyl salicylate.

[0024] Neutralizing agents, as opposed to the masking agents,effectively remove smells or the mechanisms which bring about malodor inthe mouth. Plaque causing bacteria in the mouth produces malodor due tothe acidic byproducts given off through the bacteria's metabolism ofcarbohydrates. Additionally, residual odor producing molecules are alsodeposited in the mouth after tobacco consumption and ingestion ofcertain foods. Agents which assist in the neutralization of acidicconditions brought about by plaque producing bacteria includebicarbonate and effective salts thereof due to their release ofneutralizing ions. Citrus flavorings and citric acid also serve toneutralize odors remaining after tobacco or food consumption.

[0025] The combined composition may be formulated into an orallyingestible composition and may be, for example, in liquid form, anorally dissolvable tablet or a powder. If the composition is formulatedinto a liquid form, it may be delivered to the user through a spray.

[0026] In a most preferred embodiment, the Plantago major extract, in ahomeopathic 1×(1:10 dilution) is combined into a formulation with water,a pharmaceutically acceptable base, 8% to 10% ethyl alcohol and apredetermined amount of an odor masking, antiseptic or neutralizingagent such as spearmint, citrus flavoring or thymol. Said formulation isthen placed into a pressurized spray canister. The canister is acommonly know spray dispenser, including a cap which releases thecontents upon applied pressure from a finger. In use, a person whichorally utilizes or consumes tobacco products may spray the product intothe mouth.

[0027] The product may be used as part of a tobacco utilizationcessation program and used at specific or regular intervals throughoutthe day. Alternatively, if the user has reduced their intake of tobaccoproducts they may then use the product only as the need arises. Thetobacco odor diminishing additive, masking, antiseptic or neutralizingagent of the composition of the present invention is therefore useful toreduce tobacco utilization or consumption as well as mask or neutralizethe odor of tobacco or use an antiseptic. As the tobacco use diminishes,the need for the diminishing additive, masking, antiseptic orneutralizing agent also decreases.

[0028] The foregoing description of a preferred embodiment of theinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Obviously, many modificationsand variations will be apparent to practitioners skilled in this art. Itis intended that the scope of the invention be defined by the followingclaims and their equivalents.

What is claimed is:
 1. An orally administered composition for reducingtobacco consumption, comprising: a base ingredient; a predeterminedamount of Plantago major; and a predetermined amount of an additive fordiminishing the odor characteristics of tobacco.
 2. A compositionaccording to claim 1, wherein the Plantago major is a homeopathicpreparation.
 3. A composition according to claim 1, wherein saidadditive for diminishing the odor characteristics of tobacco includes amasking agent.
 4. A composition according to claim 3, wherein saidmasking agent includes one of mint, licorice, cherry, cinnamon,spearmint, peppermint, anis, garlic, cloves and coffee.
 5. A compositionaccording to claim 1, wherein said additive for diminishing the odorcharacteristics of tobacco includes an antiseptic agent.
 6. Acomposition according to claim 5, wherein said antiseptic agent includesone of an antiseptically effective amount of alcohol, thymol, menthol,eucalyptol and methyl salicylate.
 7. A composition according to claim 1,wherein said additive for diminishing the odor characteristics oftobacco includes a neutralizing agent.
 8. A composition according toclaim 7, wherein said neutralizing agent includes one of bicarbonate oran effective salt thereof, citrus extract and citric acid.
 9. Acomposition according to claim 1, wherein said base ingredient is inliquid form.
 10. A composition according to claim 1, wherein said baseingredient is in solid form.
 11. A method for reducing tobaccoconsumption of a human, while providing fresh breath, comprising:preparing a compound comprising Plantago major; providing an additivefor diminishing the odor characteristics of tobacco; combining saidPlantago major and said additive to formulate a composition whichdiminishes tobacco consumption while diminishing the odorcharacteristics of tobacco; and orally administering said composition toa human.
 12. A method according to claim 11, wherein the oraladministration is carried out through a spray.
 13. A method according toclaim 11, further including formulating said composition into a liquid.14. A method according to claim 11, further including forming saidcomposition into an orally dissolvable tablet.
 15. A method according toclaim 11, where preparing a compound comprising Plantago major includespreparing said compound homeopathically.
 16. A method according to claim11, where preparing a compound comprising Plantago major includespreparing said compound through alcohol extraction.
 17. A methodaccording to claim 11, where preparing a compound comprising Plantagomajor includes preparing said compound through water extraction.